Depending upon the severity of the wound, the proliferative phase and final maturation of the wound to complete scar tissue can take from days up to years. Wound healing utilizes an extremely complex array of integrated biochemical events involving a regulated cascade of inter and intra cellular events. The biochemical response at the cellular level is a process involving intricate interactions among different cell functions, which include energy production, structural proteins, wound healing growth factors, proteinases, and microbial removal. Once a wound occurs, each of these cellular functions is critical to the healing process. If infection or other wound antagonists are encountered, then there is a delay in the wound healing and subsequent consequences which can be fatal. In addition, depending upon the physical condition of the patient, chronic wounds can develop which may take years to heal and lead to significant morbidity and treatment costs. Therefore, obstruction to any phase of the wound healing process can lead to complications and possible formation of a chronic wound, long term hospital stay with increased risk of a nosocomial infection, disability, and/or death. Currently, many treatment protocols for wound healing involve the use of molecular stimulators such as nucleotides, polysaccharides, and/or proteins (generally referred to as growth factors), and antioxidants. These cellular molecules function to incite cellular matrix formation, angiogenesis and other response(s) within the wound to enhance the healing process. In addition, different classes of drugs are applied to wounds such as hemostatic drugs, anti-inflammatory drugs, analgesic drugs, and angiogenesis drugs.
However, since there are numerous metabolic events that occur during the wound healing processes, it is generally believed that none of these conventional wound healing methods are an all en-compassing solution to efficient and safe wound healing. In addition, these wound healing compounds do not address the problem of infection control. Some of the limitations for many of these conventional wound healing treatments are the inability to efficiently deliver these compounds to deep wound cells involved in wound healing, inability to address the problem of infection control with sanitizers and/or antibiotics, and/or cost justification for affordable treatment plans.
Today's primary therapy for wound infection involves the use of either topical application of antiseptics and/or systemic and topical use of antibiotics. The general perspective is that topical application of antibiotics to wounds has no advantages over the use of other antiseptic methods and may increase the risk of delayed wound-healing by producing a sovereign bacterium that is resistant within the wound. Silver based dressings for treatment of infections is widely used in wound treatments. There are several of these commercially available such as Acticoatt™, Aquacels Ag®, Contreet® Foam, PolyMem® Silver, Urgotul® SSD. Unfortunately, these silver containing dressings do not kill spores or biofilms and require long exposure times that may result in cytotoxicity to the patient's own cells. The cytotoxic effect explains, in part, the clinical observation of delayed wound healing or inhibition of wound epithelialization after the use of certain topical silver dressings. Other widely used sanitizers are chlorhexidine, Betadine, which is a compound of various compounds including iodine, polyhexanide (Prontosan®), hydrogen peroxide, as well as others. All of these compounds are known to be toxic to the healthy cells in and around the wound when used extensively. In addition, these anti-disinfectants have potential efficacy restrictions and can be counter productive to wound healing due to the cellular toxicity.
It is well known that infection is the number one variable to cause wound healing complications and subsequent dire medical consequences to the patient. With the rising number of cases of drug resistant sepsis infections, there is an urgent need for a composition that can effectively treat drug resistant sepsis infection without cytotoxicity to the cells and be applied in different matrices. A somewhat new practice for treating wound infections involves delivery of antibiotic drug compounds in some form of bandage or dressing. The wound healing advantages include the ability of the solid bandage matrices to provide protection while allowing oxygen penetration and moisture influx to the wound. However, continued exposure of the bandages/dressings in combination with the current antibiotics and antiseptics for disinfection lends itself to cytotoxicity and allergic reactions in the patient. Therefore, the ultimate need is an application using a combinational bandage with the wound healing advantages of the bandage/dressing material with a synergistic additive which is both antimicrobial and hastens wound healing without cytotoxicity.
The peracid compounds are prepared as a composition in an aqueous phase whereby they exist in equilibrium with the coordinated oxidizer. The peracid compounds present in this composition are however susceptible to degradation and loss of activity with dilution and long term exposure to water. This presents a formulation challenge for incorporating peracid compounds into aqueous bandages/dressings such as hydrogels and other aqueous wound treatment matrices.